QA Program ManagerHybrid - 3 Days Onsite • Research Triangle Park, NC
The RoleWe are seeking a talented QA Program Manager to join our team. In this role, you will lead the Regulatory Affairs/Quality Assurance (QA) function to develop, implement, monitor, and maintain quality systems and policies, and to ensure compliance risks are identified and mitigated.
What You'll Do- Serve as the regulatory affairs and quality assurance resource for all functional areas of the company, particularly as related to the use of Real World Evidence.
- Act as a consultant on regulatory strategy matters.
- Lead risk assessments and audits of processes and systems.
- Oversee all aspects of the Quality Management System (QMS).
- Review vendor-supplied data and quality records for conformance to Good Documentation Practices (GDP).
- Lead the development and management of company-wide Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Support functional teams in the development of SOPs and WIs specific to their areas.
- Develop and maintain Good Clinical Practice (GCP) and Good Pharmacoepidemiology Practices (GPP) compliance processes to control the quality of work.
- Maintain current knowledge of GCP/GPP guidance and regulations, and proactively inform management and program teams of relevant changes and compliance issues.
- Manage the internal SOP training program for all employees, ensuring organization-wide compliance and refining the program as needed.
What You'll Bring- Bachelor's degree in a Life Sciences discipline or related field, with 5+ years of relevant experience.
- Experience working with pharmaceutical companies and Contract Research Organizations (CROs).
- Knowledge of evolving regulatory standards as they apply to Real World Evidence.
- Experience in real world evidence, registries, observational studies, third-party data analysis, or non-interventional research strongly preferred.
- Demonstrated ability to partner with and guide multi-disciplinary teams from project inception through completion, including FDA requirements, agency inspections, vendor audits, and corrective actions.
Nice to Have- RAC (Regulatory Affairs Certification) or equivalent credential.
- Familiarity with FDA Real World Evidence guidance frameworks.
- Experience with 21 CFR Part 11 electronic records and signatures compliance.
What We Offer- Hybrid work environment - 3 days onsite per week.
- Comprehensive health, dental, and vision coverage for you and your family.
- 401(k) with company match.
- Generous PTO and company holidays.
- Paid parental leave.
If you are ready to be part of a team where your work truly matters- where your expertise is valued, your growth is supported, and your contributions help shape the future of healthcare- Headwater Science is the place for you. We're building something meaningful together, and we'd love for you to be a part of it.
